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S2 racepinephrine hydrochloride 11.25 mg/.5mL Solution, 30 pouches — NDC 00487-5901-99 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

S2 racepinephrine hydrochloride 11.25 mg/.5mL Solution, 30 pouches — NDC 0487-5901-99 (Billing 00487-5901-99)

by Nephron Pharmaceuticals Corporation · 30 POUCH in 1 CARTON / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE

This is a package of 30 pouches of S2 racepinephrine hydrochloride 11.25 mg/.5mL Solution from Nephron Pharmaceuticals Corporation, marketed since Jan 2000 and currently FDA-listed. It is this product's only package size.

NDC 00487-5901-99
🏷️ FDA NDC (as labeled) 0487-5901-99 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0487-5901-99 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0487 labeler · 5901 product · 99 package
Package marketed since
Jan 1, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 0487590199 9
Medicaid fills, this package
3,456 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (2)
Class II · Jan 13, 2023 · Terminated — Short Fill (Nephron Sc Inc) · FDA recall D-0176-2023
Class II · Jun 29, 2022 · Terminated — CGMP Deviations: products were stored outside the drug label specifications. (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1325-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0487-5901-99
Product NDC 0487-5901
11-digit billing NDC 00487590199
NCPDP billing unit EA — each (per item)
RxCUI 310133, 863968
UNII 336096P2WE
Application # M012
SPL Set ID dd1b35c7-b23b-4b95-8162-df3d263fe32e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2000-01-01
Route RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance RACEPINEPHRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 44202060012530
GPI class S2 (Racepinephrine)
GCN Seq No 054686
GCN 22696
HICL code 025002
Ingredient (HICL) Racepinephrine Hcl
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A1
Therapeutic class — intermediate (HIC2) Cardiac Stimulants
HIC3 code A1D
Therapeutic class — specific (HIC3) General Bronchodilator Agents
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name S2 RACEPINEPHRINE 2.25% SOLN
FDB brand name S2 Racepinephrine
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 054686
  • GCN: 22696
  • GPI-14 (Medi-Span): 44202060012530
  • HICL (First Databank): 025002
  • AHFS class code: 12:12.12.00
  • RxCUI (RxNorm): 310133
Why two NDCs? The FDA registers this code as 0487-5901-99 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00487-5901-99. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name S2 RACEPINEPHRINE 2.25% SOLN Ingredient Racepinephrine Hcl
🧪 What is this product?

This is an over-the-counter inhalation solution containing racepinephrine hydrochloride, a form of epinephrine that is breathed in through the mouth and lungs. Racepinephrine is typically used to temporarily relieve symptoms of croup (a condition causing barking cough and breathing difficulty, mainly in young children) by helping to reduce swelling in the airway. This product is marketed under the FDA's OTC monograph rules for its drug category rather than through individual product approval.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $15.77 $236.61 / 15 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00487-5901-99 You're viewing this Main listing 30 POUCH in 1 CARTON / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE 2000-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
S2 11.25 mg/.5mLthis 00487-5901-99 Nephron 30 pouches — — FDA listed —
NebuClear MD 11.25 mg/.5mL 73117-0523-18 Blue 20 ml — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2000
On the market since
Jan 2000
📍
2026
Currently FDA-listed
26 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesAscorbic acid, citric acid, edetate disodium, water for injection.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNephron Pharmaceuticals Corporation
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00487
First marketedJan 2000
Product typeHuman Otc Drug
Portfolio12 products on file

More NDCs from Nephron Pharmaceuticals Corporation labeler code 00487

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses For temporary relief of mild symptoms of intermittent asthma: Wheezing Tightness of chest Shortness of breath

⏱️ Dosage and Administration 94 words ▾

Directions The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine. Do not use more than directed For use in a hand-held rubber bulb nebulizer: Add 0.5 ml (contents of one vial) of solution to nebulizer. Adults and children 4 years of age and over: 1 to 3 inhalations not more often than every 3 hours.

Do not use more than 12 inhalations in 24 hours. The use of this product by children should be supervised by an adult. Children under 4 years of age: ask a doctor.

⚠️ Warnings ~2 min read ▾

Warnings Warnings Asthma alert Because asthma may be life threatening, see a doctor if you: Are not better in 20 minutes Get worse Need more than 12 inhalations in 24 hours Use more than 9 inhalations in 24 hours for 3 or more days a week Have more than 2 asthma attacks in a week These may be signs that your asthma is getting worse. Do not use: Unless a doctor said you have asthma If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.

If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. If product is brown in color or cloudy If its color is pinkish or darker than slightly yellow or if it contains a precipitate. Ask a doctor before use if you have: Ever been hospitalized for asthma Heart disease High blood pressure Diabetes Thyroid disease Seizures Narrow angle glaucoma A psychiatric or emotional condition Trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are: Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.

Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain). Stop use and ask a doctor if: Your asthma is getting worse (See Asthma alert ) You have difficulty sleeping You have a rapid heartbeat You have tremors, nervousness, or seizure When using this product: Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.

Your risk of heart attack or stroke increases if you: Have a history of high blood pressure or heart disease Take this product more frequently or take more than the recommended dose. Avoid foods or beverages that contain caffeine Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect. If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 48 words ▾

Other Information Protect from light. Avoid excessive heat. Protect from freezing. Store between 2°C and 25°C (36°F and 77°F). How Supplied: S 2 ® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials. NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.

🧪 Active Ingredient 17 words ▾

Active ingredient (in each 0.5 ml) Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).

🧪 Inactive Ingredients 11 words ▾

Inactive Ingredients Ascorbic acid, citric acid, edetate disodium, water for injection.

🎯 Purpose 2 words ▾

Purpose Bronchodilator

📄 Do Not Use 86 words ▾

Do not use: Unless a doctor said you have asthma If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product. If product is brown in color or cloudy If its color is pinkish or darker than slightly yellow or if it contains a precipitate.

📄 Ask a Doctor Before Use If 38 words ▾

Ask a doctor before use if you have: Ever been hospitalized for asthma Heart disease High blood pressure Diabetes Thyroid disease Seizures Narrow angle glaucoma A psychiatric or emotional condition Trouble urinating due to an enlarged prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 41 words ▾

Ask a doctor or pharmacist before use if you are: Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions. Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).

📄 When Using This Product 79 words ▾

When using this product: Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death. Your risk of heart attack or stroke increases if you: Have a history of high blood pressure or heart disease Take this product more frequently or take more than the recommended dose.

Avoid foods or beverages that contain caffeine Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.

📄 Stop Use and Ask a Doctor If 31 words ▾

Stop use and ask a doctor if: Your asthma is getting worse (See Asthma alert ) You have difficulty sleeping You have a rapid heartbeat You have tremors, nervousness, or seizure

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 13 words ▾

Questions? 1-800-443-4313 Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).

📄 Package Label / Principal Display Panel 29 words ▾

PACKAGE LABEL, PRINCIPAL DISPLAY PANEL Principle Display - Pouch Label (Individually Wrapped Vial) NDC 0487-5901-99 Principle Display - Carton (30 Individually Wrapped Vials) NDC 0487-5901-99 Foil Wrap Racepinephrine Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.5K
Units reimbursed last 4 qtrs
3.4K
Gross reimbursed last 4 qtrs
$54.3K
Avg / prescription
$15.70
Avg / unit
$15.7723
Latest quarter Q1 2026
666Rx
Fee-for-service vs managed care ⓘ
91% MCO
Fee-for-service · 322 Rx Managed care · 3,134 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: 19 units · 1.7 per 100k residents MT North Dakota: no data reported ND Minnesota: 13 units · 0.2 per 100k residents MN Wisconsin: 39 units · 0.7 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: 161 units · 11.5 per 100k residents NH Oregon: 34 units · 0.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 25 units · 0.2 per 100k residents IL Indiana: 54 units · 0.8 per 100k residents IN Ohio: 159 units · 1.3 per 100k residents OH Pennsylvania: 39 units · 0.3 per 100k residents PA New Jersey: no data reported NJ Massachusetts: 356 units · 5.1 per 100k residents MA California: 802 units · 2.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 1,218 units · 26.9 per 100k residents KY West Virginia: no data reported WV Virginia: 66 units · 0.8 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 29 units · 1.4 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 345 units · 4.8 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 83 units · 2.8 per 100k residents MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.226.9
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 26.9 /100k
2 New Hampshire 11.5 /100k
3 Massachusetts 5.1 /100k
4 Tennessee 4.8 /100k
5 Mississippi 2.8 /100k
6 California 2.1 /100k
7 Montana 1.7 /100k
8 New Mexico 1.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Racepinephrine hydrochloride — the ingredient across all brands.

Top reported reactions

Asthma15
Erythema15
Pruritus15
Acquired Factor V Deficiency14
Bronchopulmonary Aspergillosis Allergic14
Chronic Obstructive Pulmonary Disease14
Coagulation Factor Deficiency14

Age at onset

Adult2
Elderly7

Reporter sex

42 reports
Male · 58%
Female · 39%
Unknown · 3%

Serious outcomes

Life-threatening14
Hospitalization13
Death5
Disabling1
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 12 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Nephron Pharmaceuticals Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nephron Pharmaceuticals Corporation is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00487-4301-05 · Nephron 00487-6105-01 · Nephron →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.